Previously, due to the risk of cytokine release syndrome and neurological toxicities, many CAR T-cell therapies included a REMS requirement.

The FDA has removed the REMS program requirement for currently approved BCMA- and CD19-directed autologous CAR T-cell therapies.

FDA updates CAR T-cell therapy labels, easing monitoring requirements and expanding access for eligible patients in oncology.

The FDA has removed Risk Evaluation and Mitigation Strategies (REMS) for approved chimeric antigen receptor (CAR) T-cell therapies for hematologic malignancies, aiming to ease provider burden and ...

The Breyanzi REMS program and the Abecma REMS program were established due to the risk of cytokine release syndrome and neurologic toxicities.

The US Food and Drug Administration (FDA) announced that it has eliminated the Risk Evaluation and Mitigation Strategies (REMS) for currently approved BCMA- and CD19-directed autologous chimeric ...

Specifically, the FDA removed the Risk Evaluation and Mitigation Strategy (REMS) program requirements from two BCMA-directed CAR T-cell therapies for multiple myeloma — ciltacabtagene autoleucel ...

FDA eliminated REMS for six approved CAR-T therapies. Patients no longer need to stay near treatment site for two weeks or avoid driving post-therapy. Market-moving news hits Benzinga Pro first—get a ...

Cell and gene therapy leaders say the agency’s decision to remove the Risk Evaluation and Mitigation Strategies that had been ...

Considerations for the Development of Chimeric Antigen Receptor (CAR) T Cell Products: Guidance for Industry. U.S. Department of Health and Human Services, Food and Drug Administration, Center for ...

LONDON, July 30, 2018 /PRNewswire/ -- Report ScopeThe key objectives of this study are to: - Review the historical development of CAR T-cell techn ...

The FDA approved the first two CD19-targeted chimeric antigen receptor (CAR) T cell therapies: tisagenlecleucel-T (Kymriah; Novartis) and axicabtagene ciloleucel (Yescarta; Kite Pharma/Gilead ...